Congenital Hearing Loss
Conditions
Keywords
Infant Hearing Screening, Patient Navigator
Brief summary
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children. The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.
Detailed description
For Specific Arm 1: The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic. For Specific Arm 2: Patient navigators will not be used for all subjects at participating clinics.
Interventions
BEHAVIORALNavigator Guidance
Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health (NIH)
Matthew Bush, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Parallel Assignment via Stepped Wedge Trial Design
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for parent-infant dyads: 1. Infant failed a hearing screening in one or both ears before postnatal hospital discharge 2. Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics. 3. Parent able to speak either English or another language using Cyracom phone interpreting services.
Exclusion criteria
1\. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) | This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth. |
Countries
United States
Participant flow
Recruitment details
The first wave of the stepped-wedge intervention began in January 2020. In the original design, new clinics were supposed to launch every 6 months. Unfortunately, COVID shutdowns halted study activities, and the second wave was not launched until March 2021. The remaining waves occurred on a compressed timeline until the final clinic was launched in March of 2023. Once a clinic entered the intervention arm, they remained in the intervention condition until recruitment ended in September 2023.
Pre-assignment details
While the study design describes dyads consisting of infants referred to testing and their parent/guardian, only the infants are considered participants because the outcome of the study describes the number of newborn infants who do not receive diagnostic audiological testing within 3 months of birth. Parents were not considered to be enrolled participants. Participants were counted only once, separate participants are included in each period below.
Participants by arm
| Arm | Count |
|---|---|
| Navigator Arm Examination of adherence to follow-up with a navigator.
Navigator Guidance: Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result. | 1,601 |
| Non-Intervention Arm Examination of adherence to follow-up without a navigator. | 1,098 |
| Total | 2,699 |
Baseline characteristics
| Characteristic | Non-Intervention Arm | Total | Navigator Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 1098 Participants | 2699 Participants | 1601 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1098 Participants | 2699 Participants | 1601 Participants |
| Sex: Female, Male Female | 455 Participants | 1167 Participants | 712 Participants |
| Sex: Female, Male Male | 643 Participants | 1532 Participants | 889 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,601 | 0 / 1,098 |
| other Total, other adverse events | 0 / 1,601 | 0 / 1,098 |
| serious Total, serious adverse events | 0 / 1,601 | 0 / 1,098 |
Outcome results
Primary
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Time frame: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigator Arm | Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 378 Participants |
| Non-Intervention Arm | Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 336 Participants |